About this trial
The purpose of the study is to evaluate the experimental medication WD-890 compared to placebo in participants with moderate-to-severe plaque psoriasis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female participant aged 18 to 75 years(inclusive)at the time of informed consent.
Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.
Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization
Disqualifiers
Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
Class III or IV congestive heart failure by New York Heart Association Criteria
Trial design
Parallel
Treatments tested in this trial
Drug:WD-890
DrugWD-890 tablet will be administered orally.
Drug: placebo
DrugPlacebo tablet will be administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
Secondary outcomes
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Percentage of Participants Achieving PASI 90 Score at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Percentage of Participants Achieving PASI 100 Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Sponsors and contacts
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